Complementary and Alternative Medicine (CAM) for Fibromyalgia

NCT02053090 | Completed DMC

• 1 other identifier: 1K23AT006392
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an acceptability and feasibility study of two adjunctive interventions: group education with stretching; and group acupuncture. The study population will be women with primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both interventions will be 10 weeks in length and will be conducted at the Oregon Health \& Science University. The primary hypothesis is that both arms will be acceptable and feasible in the study population.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Group Acupuncture; Group Education with Stretching; Nociceptive Reflex Testing; Pain; Sleep; Fatigue

Outcome Measures

Primary Outcomes (1)

• Treatment Participation Rate

  Rates of treatment attendance in both arms

  10 weeks

Secondary Outcomes (5)

• Drop out rate

  10 and 14 weeks

• Completion of Evaluation Rates

  Weeks 0, 5, 10 and 14

• Fibromyalgia Impact Questionnaire Revised

  Weeks 0, 5, 10, and 14

• Nociceptive Reflex Testing

  Weeks 0, 5, 10 and 14

• Sleep Quality and Daily Activity

  Weeks 0, 5, 10, and 14

Study Arms (2)

Group Education with Stretching

ACTIVE COMPARATOR

Group Education with Stretching will receive 10 small group educational classes at the Oregon Health \& Science University (OHSU), based on the book "Fibromyalgia (Biographies of Disease)." Each chapter of Fibromyalgia covers different aspects of the disease and its treatment including global, economic, and risk statistics; a timeline of key events in the study of fibromyalgia; common symptoms and diagnostic indicators; natural history of fibromyalgia; pharmacologic and non-pharmacologic treatments; associated disorders and syndromes; and impact of fibromyalgia at home, in the workplace and in society at large. Participants will be informed that they should not start additional treatments until the end of the study and complementary and alternative treatments won't be covered until the last session. Participants will also receive a digital video disk (DVD) covering stretching appropriate for fibromyalgia patients and will be asked to incorporate the DVD over the next 10 weeks.

Behavioral: Group Education and Stretching

Group Acupuncture

EXPERIMENTAL

20 treatments in 10 weeks will include individualized acupuncture in a group setting, dietary and lifestyle recommendations each based on the Traditional Chinese Medicine diagnosis (zhang fu) at the time of the visit.

Procedure: Group Acupuncture

Interventions

Group Education and Stretching BEHAVIORAL

Group Education with Stretching

Group Acupuncture PROCEDURE

Group Acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia
• Having a primary Traditional Chinese Medicine (TCM) diagnosis of either Liver Qi Stagnation, Qi and Blood Stagnation, or Qi and Blood Deficiency
• Female gender
• Reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain.
• Willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study
• No TCM in last 3 months (including acupuncture, Chinese herbs or herbal tea pills, tuina (Chinese massage), shiatsu (Japanese massage), qigong and Oriental food therapy)
• Ability to travel to the intervention and testing sites up to two times weekly
• Being over 18 and under 75 years of age, and
• Capability of giving informed consent.

You may not qualify if:

• Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture;
• Individuals with celiac disease
• A score greater than 29 on the Beck Depression Inventory
• Presence of concurrent autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, that causes pain and could potentially confound the analysis;
• Routine daily use of narcotic analgesics or history of substance abuse;
• Concurrent participation in other therapeutic trials;
• Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test);
• Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years);
• Are undergoing disability determination, or are involved in litigation related to fibromyalgia
• Any impairment, activity or situation that in the judgment of the PI would prevent satisfactory completion of the study protocol
• Cognitive behavioral therapy in the last 6 months.
• Non-fluency in English

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott D Mist, PhD, MAcOM

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)